Individualized Dietary Intervention in Breastfeeding Women: Body Weight and Vitamin A Stores

Not Applicable

Completed

• Conditions: Overweight and Obesity; Dietary Modification; Vitamin A Deficiency; Breastfeeding
• Interventions: Behavioral: Nutrition guidelines; Behavioral: Intervention-Nutrition guidelines

• Registration Number: NCT03640104
• Lead Sponsor: Universidad de Sonora

Brief Summary

Breast milk is the best food during the first 6mo of life because it offers multiple benefits for the mother-infant pair. An inadequate maternal diet during pregnancy can lead to excess weight gain, leading to negative health consequences for the dyad. In Mexico, an excess of body weight coexists with micronutrient deficiencies (double burden of malnutrition). Low vitamin A concentration has been observed in northwest Mexico, which can affect the human milk composition and increase the risk of VAD in breastfed babies. An individualized dietary intervention in the lactating woman will reduce body weight and improve vitamin A status. The objective is to assess the effect of an individualized dietary intervention during 3 months postpartum on body composition and vitamin A status of lactating women.

Detailed Description

This protocol was approved by the Bioethics Committee of the Department of Medicine and Health Sciences of Universidad de Sonora. A randomized controlled trial will be carried out and participant women will be assigned by simple randomization 1:1 to either the intervention or control group, upon signing an informed consent. At baseline (2wk postpartum), anthropometric (weight, height, mid upper-arm circumference and triceps skinfold thickness) and body composition (DXA) measurements as well as the assessment of vitamin A status (serum and breastmilk retinol and the modified relative dose response) will be performed. The control group will receive only recommendations for a healthy diet in accordance with international standards and will be followed up every month to promote adherence and to assess their nutritional status. On the other hand, the intervention group will receive an individualized macronutrient meal equivalent menu, with nutritional consultations every two weeks. The dietary plan will include 1-1.5 g/kg body weight protein, 30% total fat (preferably mono and polyunsaturated fatty acids), and vitamin A sources (1300 RAE). After 3 months of intervention are completed, baseline measurements will be repeated. Statistical analysis will include descriptive stats and comparisons between groups (t-tests), significance will be defined as P \< 0.05.

Study Timeline

• Study First Submitted: 2018-08-17
• Study First Submitted QC: 2018-08-17
• Study First Posted: 2018-08-21
• Study Start: 2018-11-01
• Primary Completion: 2020-02-07
• Study Completion: 2020-02-07
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-26
• Last Update Posted: 2021-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• BMI ≥ 25
• Predominant breastfeeding
• Signed Informed Consent

Exclusion Criteria

• Multiparity
• Alcohol, drugs, tobacco intake
• Use of dietary supplements
• Active infection (C reactive protein > 6mg/L)
• External nutritional counseling
• Pregnancy during the study period
• Liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nutrition Guidelines	Nutrition guidelines	Participants will receive general nutritional recommendations according to international standards
Intervention-Nutrition guidelines	Intervention-Nutrition guidelines	Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.

Primary Outcome Measures

Name	Time	Method
Total Body weight	Baseline and 3 months after enrollment	Difference in change (between baseline and final body weight within groups) between the intervention and control group, respectively
Vitamin A liver stores	Baseline and 3 months after enrollment	Stores are calculated as the DR/R ratio. The outcome will be calculated as the difference in change (between baseline and final VA stores within groups) between the intervention and control group, respectively

Secondary Outcome Measures

Name	Time	Method
Body fat mass	Baseline and 3 months after enrollment	Difference in change (between baseline and final body fat mass within groups) between the intervention and control group, respectively
Retinol	Baseline and 3 months after enrollment	Difference in change (between baseline and final retinol concentration within groups) between the intervention and control group, respectively

Trial Locations

Locations (1)

Universidad de Sonora; 🇲🇽 Hermosillo, Sonora, Mexico